Postmarketing data on obeticholic acid (Ocaliva) identified a risk for serious liver injury in primary biliary cholangitis (PBC) patients without

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FDA Issues Safety Alert on Liver Disease Drug

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The findings of a new study indicate that patients taking the autoimmune liver disease drug Ocaliva faced a nearly 400% increased risk of developing liver disease. The U.S. Food and Drug Administration (FDA) issued a drug safety communication on December 12, warning that Ocaliva can lead to serious liver injury among patients who do not already have liver disease and increases the likelihood of needing a liver transplant and death. Ocaliva (obet…

aboutlawsuits.com

FDA Warns of Ocaliva Liver Injury Risks Linked to Autoimmune Disorder Drug

[Signs of liver disease/liver protection] Are moles on the skin likely to be a decline in liver function? Some doctors pointed out that if liver problems occur, 3 major changes will often occur on the face. This may be a sign of liver disease and requires special attention, including the appearance of this type of mole on the face! Self-test the 3 major signs of liver disease on your face; are you afraid this type of mole will catch the trick? Y…

【肝病徵兆／護肝】皮膚長痣可能是肝功能衰退？有醫生指出，若肝臟出現問題，臉部往往會出現3大變化，有機會是患上肝病的徵兆，需特別留意，當中包括臉上出現這類型的痣！ 自測肝病3大臉部徵兆 長這種痣恐中招？ 湖北省人民醫院肝病專科醫生楊麗華在社交平台撰文指，肝臟是人體最大的內臟器官，會進行解毒、代謝、合成等多種重要功能。然而，不良的生活習慣和高壓力的生活節奏，容易令肝臟受損。當肝臟出現問題時，臉部有可能

自測肝病3大臉部徵兆 長這種痣恐中招？醫生教5招護肝排毒

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Self-test the 3 major signs of liver disease on the face, can this type of mole be a trick? Doctors teach 5 tricks to protect the liver and detoxify

beckershospitalreview.com

FDA highlights injury risk for some patients on liver disease drug

The FDA said it continues to monitor the safety of Intercept Pharmaceuticals and Alfasigma’s rare liver disease drug Ocaliva after seeing evidence of “serious liver injury” in a post-approval clinical trial.
The agency announced Thursday ...

Endpoints News

'Serious liver injury' cases lead FDA to call for monitoring of Ocaliva patients

This update follows May 2021 guidelines which recommended patients with primary biliary cholangitis (PBC) with advanced cirrhosis discontinue obeticholic acid.

Pharmacy Times

FDA Reports Serious Liver Injury in Patients Without Cirrhosis Using Obeticholic Acid to Treat PBC

An FDA review of postmarket clinical trial data revealed an increased risk of liver injury with obeticholic acid in patients with PBC without cirrhosis.

hcplive.com

FDA Finds Obeticholic Acid (Ocaliva) Linked to Serious Liver Injury in Noncirrhotic PBC

The agency identified 20 cases of serious liver damage associated with Ocaliva in the latest setback for a drug once seen as a potential blockbuster.

biopharmadive.com

FDA flags additional injury risk for Intercept’s liver drug

The Food and Drug Administration (FDA) has raised new safety concerns regarding Ocaliva, a drug used to treat primary biliary cholangitis (PBC), a rare liver disease. The FDA identified 20 serious cases of liver damage, including liver transplants, listings for transplants, or liver-related deaths among patients treated with Ocaliva. These findings come after a review of clinical trial data, notably affecting patients without cirrhosis, a condit…

FDA Issues Safety Alert on Liver Disease Drug

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